固邦HAP/TCP陶瓷骨修复骨缺损的30例初步报告

目的:观察临床应用固邦HAP/TCP陶瓷骨修复骨缺损的效果和安全性。方法:2004年9月—2006年3月,选择骨折或其他骨缺损的患者30例,根据缺损部位及大小选择适量的颗粒状陶瓷骨材料5~30ml,手术前、手术后1周、4周、8周、12周分别进行X线检查,评估骨愈合和骨形成的情况,并加以评分,并且对部分病例进行了最长为72周的X线随访。观察术前、术后1周、12周的血、尿常规,肝肾功能、血钙、血磷及心电图变化情况;各时段体温、血压、心率、呼吸频率等基本生命体征,评估植入材料对于人体的安全性。结果:30例患者均随访12周以上,X线结果显示,骨缺损处形态基本或大部分恢复,疗效评分:15例达到7分,9例达到6分,优良率达到了96.7%。在随访的30例患者中,无一例出现过敏等不良反应,所有患者的生命体征和血、尿指标以及钙、磷指标在术前及术后均未出现明显变化。结论:固邦HAP/TCP陶瓷骨材料在本组骨折及骨缺损处具有引导成骨和骨性结合作用,初步临床验证该材料无毒性及过敏反应,可供临床应用于修复骨缺损。

Clinical Observation of Repairing the Bone Defects with Hydroxyapatite/Tricalcium phosphate (HAP/TCP) Composites

Objective:To evaluate the safety and efficacy of repairing the bone defect with hydroxyapatite/tricalcium phosphate(HA/TCP). Methods:A total of 30 patients with different kinds of bone defects who need surgical interference were enrolled in the open-label, non-randomized, single-arm clinical study. Each patient was implanted with different amount of HA/TCP material range from 5 to 30 ml according to the size of the bone defect during the surgical operation. On the weeks 1, 4, 8, and 12 post-operatively, the degree of the new bone formation and the bone healing at conventional roentgenography was represented at each follow-up, meanwhile, the heart rate, body temperature, blood pressure and respiration rate were also recorded. In addition, electrocardiogram, blood and urine routine tests, hepatic and renal function, serum level of the calcium and phosphate were done to determine the side effects on the weeks 1 and 12 post-operatively. Results:After the 12 weeks follow-up, almost all the 30 patients have been observed bone healed morphologically, and 96.7% of them have got a satisfying outcome. Additionally, no allergic and other side-effects took place during the whole test. Conclusion:Hydroxyapatite/Tricalcium phosphate (HA/TCP) is a good and safe substitute for treatment of the bone defects.